Senior Project Manager, Clinical Supply
About The Position
The Senior Project Manager, Clinical Supply provides input to Clinical Study Teams to influence clinical protocol design and ensure efficient use of supply chain resources. The role translates clinical study designs into packaging designs and authors the study medication and labeling section of clinical protocols. It develops protocol-specific labeling compliant with applicable global regulations. The position identifies, develops, communicates, and tracks project timelines, activities, logistics, and milestones. It coordinates protocol-specific manufacturing and packaging work orders with third-party and IRT vendors, quality assurance, clinical team partners, and others to help ensure timely availability of clinical supplies. The role also conducts clinical-supply scenario analysis, risk management, and contingency planning; forecasts bulk drug product requirements, including comparator agents, ancillary supplies, commodities, and overages; participates in cross-functional initiatives as a drug subject matter expert; and leads process-improvement initiatives.
Requirements
- Bachelor’s degree required, preferably in physical science, mathematics, engineering, or pharmacy.
- Must have experience in at least one of these areas: Drug Discovery (such as Process Chemistry or Analytical Chemistry), Drug Development (such as formulation), Clinical Operations (such as Clinical Project Management), Supply Chain (such as Clinical Supplies Project Management), or Quality Assurance.
- Proficient in applying standard business requirements, such as SOPs, global regulations, and OEC.
- Understand the importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes.
- Capable of representing CDSM as a participant in and contributor to cross-functional initiatives.
- Ability to work collaboratively across departments and functions and interact in a tactful, professional, and effective manner.
- Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
- Strong problem-solving and project-management skills.
- Strong written and oral communication skills.
Nice To Haves
- Three years of total experience in the pharmaceutical industry is preferred, but not required.
Responsibilities
- Provide input to Clinical Study Teams to influence clinical protocol design and ensure efficient use of supply chain resources.
- Translate clinical study designs into packaging designs.
- Author the study medication and labeling section of clinical protocols.
- Develop protocol-specific labeling compliant with applicable global regulations.
- Identify, develop, communicate, and track project timelines, activities, logistics, and milestones.
- Create protocol-specific manufacturing and packaging work orders in coordination with third-party and IRT vendors, quality assurance, clinical team partners, and others to support timely availability of clinical supplies.
- Conduct protocol-specific clinical supplies scenario analysis, risk management, and contingency planning.
- Forecast protocol-specific bulk drug product requirements, including comparator agents, ancillary supplies, commodities, and overages.
- Participate in cross-functional initiatives as a drug subject matter expert.
- Lead process-improvement initiatives.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligible to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
